BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a contract to potential hire Quality Assurance Supervisor to work for a leading Orange County area contract manufacturing company.
Position Summary:
The primary purpose of the QA Manufacturing Supervisor is to ensure the Quality Assurance staff and manufacturing processes are compliant with FDA Regulations as well as adhere to company policies.
Responsibilities (Duties may include, but are not limited to, the following):
- Provide leadership and training to Quality Assurance Inspectors including but not limited to performance reviews, professional development, and setting objectives.
- Develop a fully cross-functional QA team.
- Responsible for line clearances, Critical Control points, and Quality assurance parameters during the manufacturing process. As well as ensuring the processes are sufficient, FDA compliant, and lead to quality product.
- Ensure Good Documentation Practices are closely followed by staff resulting in complete and correct forms, reports, and Batch Records. Review Batch Records for next release point and reconciliation.
- Oversee the identity testing process ensuring staff has proper workflow and coverage throughout the operation.
- Assists Quality Management in the preparation of periodic management reviews and ensures appropriate follow-up on all recommended corrective action(s).
- Supports a safe, clean, and secure working environment by supporting procedures, rules, and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.
- Works closely with Operations and Operations staff making recommendations to improve and better sustain manufacturing.
- Supports the Material Review Board and drives staff to report and close Non-Conformance Reports in the Quality Management System.
- Implements lean manufacturing initiatives that focus on satisfying the corporate goals in concert with meeting customer requirements with a sense of urgency. For instance, developing and implementing efficient and effective ways to reduce waste, addressing customer requirements pursuant to the established principles of companies QMS.
- Contributes in a team effort by performing according to the guidelines outlined in company’s Code of Conduct, cGDP, cGMP, Lean principles, and other policies; supports the directives and decisions of higher-level management and performs other duties as assigned.
- Assist with quality and safety audits of company’s facilities to ensure cGMP and cGMP standards are maintained and project integrity is preserved. Work closely with management to resolve quality, production, and efficiency problems.
- Act as liaison for customers with various company departments regarding quality issues as needed.
- Assist with FDA inspections; may represent department as core or consultant member on an appointment project team.
- Other responsibilities and tasks assigned by management.
Experience/Requirements:
- B.S./B.A. in food science, Manufacturing or other related field. A.A or equivalent from 2-year college or technical school or equivalent experience in a supervisor role.
- 5+ years related experience and/or training; or equivalent combination of education and experience.
- Quality Management or Supervisor Role in a Manufacturing environment.
- Network-based systems, Quality Management Systems Software (QMS) & QAD (preferred)
- Formal Training in FDA Regulations or ASQ (preferred)
- Bilingual in Spanish (preferred)
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
